Dear Doctor Letter (Rote-Hand-Brief) on Torisel® (temsirolimus, concentrate and diluent for solution for infusion): Contamination of the diluent
2011.12.09
Active substance: temsirolimus
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the diluent prior to administration of Torisel® in order to exclude particle contamination. The background for this recommendation is the discovery of significant shortcomings in the Good Manufacturing Practice (GMP) at Ben Venue Laboratories, the manufacturing site where the diluent for Torisel® is produced.
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